The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

• The patient must have hypertension and uncontrolled SBP on monotherapy.

• Patients who have read, signed and received a copy of the informed consent prior to any study procedures

Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.

Exclusion Criteria:

• Any history of secondary hypertension

• History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months

• History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months